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OncoMatch/Clinical Trials/NCT06746688

A First-in-human, Clinical Trial Assessing the Safety of ES2B-C001-S01 With or Without [Adjuvant] in Patients With HER2-expressing Metastatic Breast Cancer.

Is NCT06746688 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies ES2B-C001 for breast cancer.

Phase 1RecruitingExpreS2ion BiotechnologiesNCT06746688Data as of Sep 2026Location: Austria

Treatment: ES2B-C001The trial is a first-in-human, phase I, open-label, dose-escalating trial to assess the safety and tolerability of ES2B-C001 combined with or without \[adjuvant\], in patients with human epidermal growth factor receptor 2 (HER2) expressing metastatic breast cancer.

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Extracted eligibility criteria

Treatments studied

Other

ES2B-C001

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) expression (ihc 1+, 2+ (fish negative or positive), or 3+)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Must have received: anticancer therapy

after undergoing 2-3 lines of anticancer therapy

Lab requirements

Blood counts

adequate bone marrow function without clinically significant laboratory parameters as judged by the investigator

Kidney function

adequate kidney function without clinically significant laboratory parameters as judged by the investigator

Liver function

adequate liver function without clinically significant laboratory parameters as judged by the investigator

Cardiac function

adequate heart function without clinically significant laboratory parameters as judged by the investigator; 12-lead ECG without clinically significant abnormalities and no LBBB, QRS duration >140ms, or evidence of prior infarction; Echocardiography with LVEF <55%; Previous documented coronary artery disease or congestive heart failure (>NYHA II)

Patients have adequate bone marrow, kidney, liver, heart, and lung function without clinically significant laboratory parameters as judged by the investigator. 12-lead ECG without clinically significant abnormalities and no LBBB, QRS duration >140ms, or evidence of prior infarction. Echocardiography with LVEF <55%. Previous documented coronary artery disease or congestive heart failure (>NYHA II).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06746688 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received anticancer therapy.

Does this trial require ERBB2?

Yes, ERBB2 expression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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